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Re: numbersarefun post# 32

Friday, 08/30/2019 1:21:21 PM

Friday, August 30, 2019 1:21:21 PM

Post# of 169
Numbers- In my opinion, I think the FDA has already responded to IPCI and said it needed to re-evaluate approval criteria for opioids like Oxy... My guess is whatever they decide, this product will be left in limbo because the FDA will move at a smail's pace on this. And when they decide how to evaluate these drugs, I am sure it will have additional criteria, etc. that IPCI's application does not cover or meet. Bottom line is Rexista is a dead product... I blame Odidi. He submitted a half ass application that did not include oral or nasal HAP studies. He is a moron for thinking that would fly. If he had submitted a complete application, he might have got approval the first time through... But he didn't... Now he can push blame on FDA and say they changed the rules on us. But bottom line is if he would have submitted a complete application first time around, maybe he would have gotten approval.
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